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Short Term Refractive and Ocular Parameter Changes After Topical Atropine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03839888
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief Summary:
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.

Condition or disease Intervention/treatment Phase
Myopia, Left Eye Drug: 0.125% Atropine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Term Refractive and Ocular Parameter Changes After Topical Atropine
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 0.125% atropine group
patients used the 0.125 % atropine eyedrop every night before sleep for 7 days
Drug: 0.125% Atropine
patients used 0.125% atropine eyedrop per night before sleep for 7 days.

Primary Outcome Measures :
  1. SER [ Time Frame: change from SER at 7 days ]
    Spherical equivalent refractive error

Secondary Outcome Measures :
  1. AL [ Time Frame: change from AL at 7 days ]
    Axial length

  2. ACD [ Time Frame: change from ACD at 7 days ]
    anterior chamber depth

  3. IOP [ Time Frame: change from IOP at 7 days ]
    intraocular pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion Criteria:

  • Patients who had already been undergoing cycloplegic treatment for myopia before.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Identifier: NCT03839888    
Other Study ID Numbers: BuddhistTCGHTaipei2
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
axial length
anterior chamber depth
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action